Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals L...

FDA Drug Recall #D-0459-2025 — Class II — May 9, 2025

Recall Summary

Recall Number D-0459-2025
Classification Class II — Moderate risk
Date Initiated May 9, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alembic Pharmaceuticals Limited
Location Panchmahal
Product Type Drugs
Quantity 2,946 500-count bottles

Product Description

Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71

Reason for Recall

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

Distribution Pattern

Distributed Nationwide and in PR

Lot / Code Information

Batch 2405014780, Exp. Date: Sep. 30, 2027

Other Recalls from Alembic Pharmaceuticals Limited

Recall # Classification Product Date
D-0248-2026 Class III Fesoterodine Fumarate, Extended-release Tablets... Dec 16, 2025
D-0156-2026 Class III Fesoterodine Fumarate, Extended-release Tablets... Oct 10, 2025
D-0566-2025 Class II Doxepin Hydrochloride Capsules, USP, 10 mg, 100... Jul 25, 2025
D-0447-2025 Class II Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bot... May 7, 2025
D-0326-2021 Class I Telmisartan Tablets, USP 20 mg, 30-count bottle... Mar 17, 2021

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.